Drug · FAERS side-effect profile with label screen
Atogepant side effects: what 6,566 FDA adverse event reports show
Drug class
Calcitonin Gene-related Peptide Receptor Antagonist
FDA label (Established Pharmacologic Class)
Brand names
Qulipta
openFDA label
Who reports
6,566 reports · 36% serious · 76 with death outcome · 86% female
openFDA FAERS counts, all years, deduplication not applied
Used for
QULIPTA is indicated for the preventive treatment of migraine in adults. QULIPTA is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. ( 1 )
FDA label, Indications and Usage
What it is
The active ingredient of QULIPTA is atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 11Not in label — unassessed 25
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 193 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Migraine | 1,164 | 39.6 37.6–41.8ROR 48.0 · χ² 43,467 / p <1e-300 | 39.1 EB05 37.3 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 38.5 · 91% consumer | no trial data cached |
| Brain fog | 52 | 11.4 8.7–15.0ROR 11.5 · χ² 482 / p 3e-107 | 11.1 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · 79% consumer | no trial data cached |
| Spinal operation | 39 | 10.3 7.5–14.1ROR 10.4 · χ² 318 / p 2e-71 | 9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 · 92% consumer | no trial data cached |
| Therapy interrupted | 197 | 9.1 8.0–10.5ROR 9.4 · χ² 1,421 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 90% consumer | no trial data cached |
| Brain neoplasm | 23 | 8.0 5.3–12.0ROR 8.0 · χ² 134 / p 3e-31 | 7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 · 100% consumer | no trial data cached |
| Therapeutic product effect incomplete | 151 | 6.8 5.8–8.0ROR 7.0 · χ² 747 / p 1e-164 | 6.7 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 89% consumer | no trial data cached |
| Constipation | 453 | 6.7 6.1–7.3ROR 7.1 · χ² 2,207 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Impaired gastric emptying | 26 | 6.5 4.4–9.6ROR 6.5 · χ² 116 / p 3e-27 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Product use complaint | 27 | 5.6 3.8–8.1ROR 5.6 · χ² 97 / p 4e-23 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=8 | no trial data cached |
| Therapeutic response shortened | 52 | 5.2 4.0–6.8ROR 5.3 · χ² 173 / p 7e-40 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Surgery | 94 | 5.2 4.2–6.3ROR 5.2 · χ² 314 / p 2e-70 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · 80% consumer | no trial data cached |
| Head discomfort | 28 | 5.1 3.5–7.4ROR 5.1 · χ² 88 / p 4e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 93% consumer | no trial data cached |
| Knee operation | 15 | 4.9 3.0–8.2ROR 4.9 · χ² 43 / p 2e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Photophobia (light sensitivity) | 28 | 4.8 3.3–6.9ROR 4.8 · χ² 80 / p 2e-19 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 75% consumer | no trial data cached |
| Peripheral coldness | 18 | 4.2 2.6–6.6ROR 4.2 · χ² 40 / p 1e-10 | 3.8 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Brain injury | 13 | 4.1 2.4–7.1ROR 4.1 · χ² 28 / p 7e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Pharyngeal swelling | 12 | 4.0 2.3–7.1ROR 4.0 · χ² 24 / p 5e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Therapeutic product effect decreased | 54 | 3.9 3.0–5.1ROR 3.9 · χ² 113 / p 1e-26 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 77% consumer | no trial data cached |
| Disability | 24 | 3.9 2.6–5.8ROR 3.9 · χ² 48 / p 2e-12 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 96% consumer | no trial data cached |
| Feeding disorder | 24 | 3.8 2.6–5.7ROR 3.9 · χ² 48 / p 2e-12 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 96% consumer | no trial data cached |
| Knee arthroplasty | 23 | 3.5 2.3–5.3ROR 3.5 · χ² 39 / p 2e-10 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 87% consumer | no trial data cached |
| Headache | 642 | 3.3 3.0–3.5ROR 3.5 · χ² 1,043 / p 4e-229 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 86% consumer | no trial data cached |
| Paraesthesia oral | 14 | 3.1 1.8–5.3ROR 3.1 · χ² 18 / p 1e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Abnormal dreams | 27 | 3.1 2.1–4.5ROR 3.1 · χ² 36 / p 8e-10 | 3.0 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 70% consumer | no trial data cached |
| Menstruation delayed | 10 | 3.1 1.7–5.7ROR 3.1 · χ² 12 / p 3e-4 | 2.8 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious n=4 | no trial data cached |
| Amenorrhoea (missed periods) | 16 | 3.1 1.9–5.0ROR 3.1 · χ² 20 / p 3e-6 | 2.9 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Tinnitus (ringing in the ears) | 44 | 3.1 2.3–4.1ROR 3.1 · χ² 59 / p 9e-15 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 77% consumer | no trial data cached |
| Hereditary angioedema | 10 | 3.0 1.6–5.7ROR 3.0 · χ² 12 / p 3e-4 | 2.8 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Infusion site pain | 12 | 3.0 1.7–5.3ROR 3.0 · χ² 14 / p 9e-5 | 2.8 EB05 1.7 · IC025 +0.5 | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Gastroenteritis viral | 17 | 3.0 1.9–4.8ROR 3.0 · χ² 21 / p 3e-6 | 2.8 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Seizure | 104 | 2.9 2.4–3.5ROR 2.9 · χ² 128 / p 7e-30 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 83% consumer | no trial data cached |
| Fibromyalgia | 22 | 2.9 1.9–4.4ROR 2.9 · χ² 25 / p 2e-7 | 2.8 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 3.9 · 86% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 80 | 2.8 2.2–3.5ROR 2.8 · χ² 90 / p 1e-21 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 74% consumer | no trial data cached |
| Vertigo (spinning dizziness) | 53 | 2.8 2.1–3.6ROR 2.8 · χ² 59 / p 1e-14 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 85% consumer | no trial data cached |
| Illness | 87 | 2.8 2.2–3.4ROR 2.8 · χ² 97 / p 4e-23 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 82% consumer | no trial data cached |
| Drug effect less than expected | 12 | 2.7 1.5–4.8ROR 2.7 · χ² 11 / p 4e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Reporting / coding artifact | serious n=4 | no trial data cached |
| Panic attack | 31 | 2.7 1.9–3.9ROR 2.7 · χ² 32 / p 8e-9 | 2.6 EB05 2.0 · IC025 +0.8 | Not in label — unassessed | serious PRR 3.5 · 79% consumer | no trial data cached |
| Loss of personal independence in daily activities | 40 | 2.7 2.0–3.7ROR 2.7 · χ² 41 / p 9e-11 | 2.6 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 88% consumer | no trial data cached |
| Nephrolithiasis (kidney stones) | 38 | 2.7 1.9–3.6ROR 2.7 · χ² 38 / p 4e-10 | 2.6 EB05 2.0 · IC025 +0.8 | Not in label — unassessed | serious PRR 4.2 · 76% consumer | no trial data cached |
| Intentional dose omission | 22 | 2.6 1.7–3.9ROR 2.6 · χ² 20 / p 5e-6 | 2.5 EB05 1.7 · IC025 +0.6 | Reporting / coding artifact | serious PRR 7.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Migraine | 1,164 | 39.6 37.6–41.8ROR 48.0 · χ² 43,467 / p <1e-300 | 39.1 EB05 37.3 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 38.5 · 91% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 792 | 1.9 1.8–2.1ROR 2.0 · χ² 372 / p 4e-83 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.3 · 83% consumer | no trial data cached |
| Headache | 642 | 3.3 3.0–3.5ROR 3.5 · χ² 1,043 / p 4e-229 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 86% consumer | no trial data cached |
| Nausea | 605 | 2.4 2.3–2.6ROR 2.6 · χ² 537 / p 4e-119 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 72% consumer | no trial data cached |
| Constipation | 453 | 6.7 6.1–7.3ROR 7.1 · χ² 2,207 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Fatigue (tiredness) | 425 | 1.7 1.6–1.9ROR 1.8 · χ² 140 / p 1e-32 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 · 83% consumer | no trial data cached |
| Dizziness | 265 | 1.7 1.5–1.9ROR 1.7 · χ² 77 / p 7e-19 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 · 75% consumer | no trial data cached |
| Therapy interrupted | 197 | 9.1 8.0–10.5ROR 9.4 · χ² 1,421 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 90% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 171 | 2.4 2.0–2.7ROR 2.4 · χ² 134 / p 3e-31 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 73% consumer | no trial data cached |
| Therapeutic product effect incomplete | 151 | 6.8 5.8–8.0ROR 7.0 · χ² 747 / p 1e-164 | 6.7 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 89% consumer | no trial data cached |
| Anxiety | 145 | 1.6 1.4–1.9ROR 1.6 · χ² 35 / p 2e-9 | 1.6 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.8 · 87% consumer | no trial data cached |
| Somnolence (drowsiness) | 138 | 2.2 1.9–2.6ROR 2.2 · χ² 89 / p 2e-21 | 2.2 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 · 83% consumer | no trial data cached |
| Covid-19 | 133 | 2.4 2.0–2.8ROR 2.4 · χ² 108 / p 1e-25 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 80% consumer | no trial data cached |
| Feeling abnormal | 129 | 1.7 1.4–2.0ROR 1.7 · χ² 38 / p 4e-10 | 1.7 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.7 · 88% consumer | no trial data cached |
| Alopecia (hair loss) | 124 | 2.0 1.7–2.4ROR 2.0 · χ² 63 / p 1e-15 | 2.0 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.2 · 74% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Brain fog — n=52, PRR 11.4
- Brain neoplasm — n=23, PRR 8.0
- Impaired gastric emptying — n=26, PRR 6.5
- Head discomfort — n=28, PRR 5.1
- Photophobia — n=28, PRR 4.8
- Feeding disorder — n=24, PRR 3.8
- Knee arthroplasty — n=23, PRR 3.5
- Headache — n=642, PRR 3.3
- Abnormal dreams — n=27, PRR 3.1
- Tinnitus — n=44, PRR 3.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Atogepant?
In FDA FAERS, the most frequently co-reported reaction terms for Atogepant are migraine, headache, nausea, constipation, fatigue, dizziness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Atogepant have an FDA boxed warning?
No. The FDA label retrieved for Atogepant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atogepant causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 8c8ab8f4-32bd-497a-befa-70c8a51d8d52, effective 20250930; matched on
openfda.generic_name.exact:"ATOGEPANT") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 233 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.